Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolesc… (NCT06111586) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS)
United States, Austria, Belgium197 participantsStarted 2023-12-11
Plain-language summary
This is a randomized, parallel group, double-blind Phase 2 study with a blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment.
Study details include:
Screening period: at least 3 weeks and up to 5 weeks. Enrollment date of the participant must take into consideration this constraint)
Double-blind treatment period (104 weeks for Part A and Part B; 52 weeks for Part C):
Main treatment period: 52 weeks for Parts A and B, 26 weeks for Part C Blinded extension: 52 weeks (for Part A and Part B, 26 weeks for Part C) Optional OLE period: 104 weeks for all parts Safety follow-up: 26 weeks The treatment duration will be up to 104 weeks for Part A and Part B or 52 weeks for Part C, the total study duration will be up to 135 weeks for Part A and Part B or 83 weeks for Part C.
If participants enter the OLE period, the treatment duration will be up to 208 weeks for Part A and Part B or 156 weeks for Part C, and the total study duration will be 240 weeks approximately for Part A and Part B or 188 weeks for Part C.
Who can participate
Age range
6 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants who meet the criteria of T1D according to American Diabetes Association
* Initiated exogenous insulin replacement therapy not longer than 90 days prior to screening visit at which random C-peptide will be assessed (V1).
* Receiving at least one of the following T1D standard of care (SOC), insulin hormone replacement therapy
* one or multiple daily injections (MDI) of basal insulin, prandial insulin and/or premixed insulin, or
* continuous subcutaneous insulin infusion (CSII)
* Participants must be positive for at least 1 of the following T1D autoantibodies confirmed by medical history and/or obtained at study screening:
* Glutamic acid decarboxylase (GAD-65)
* Insulinoma Antigen-2 (IA-2)
* Zinc-transporter 8 (ZnT8) or
* Insulin (if obtained not later than 10 days after exogenous insulin therapy initiation)
* Have random C-peptide levels ≥ 0.2 nmol/L determined at screening visit.
* Be vaccinated according to the local vaccination schedule. Any vaccinations should take place at least 28 days prior to randomization for non-live vaccines and at least 3 months prior to randomization for live vaccines.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* Participants body weight at screening must be at least 20kg.
Exclusion Criteria:
* Serious systemic viral, bacterial or fungal infection (eg, pneumonia, pyelonephritis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W52 for Part B (12-21 y.o.)
Timeframe: Baseline to Week 52
2
Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W26 for Part C (6-11 y.o.)